author Gerald Posner traces the heroes and villains of the trillion-dollar-a-year pharmaceutical industry and uncovers how those once entrusted with improving life have often betrayed that ideal to corruption and reckless profiteering—with deadly consequences. Pharmaceutical breakthroughs such as antibiotics and vaccines rank among some of the greatest advancements in human history. Yet exorbitant prices for life-saving drugs, safety recalls affecting tens of millions of Americans, and soaring rates of addiction and overdose on prescription opioids have caused many to lose faith in drug companies. Now, Americans are demanding a national reckoning with a monolithic industry. Pharma introduces brilliant scientists, in-corruptible government regulators, and brave whistleblowers facing off against company executives often blinded by greed. A business that profits from treating ills can create far deadlier problems than it cures. Addictive products are part of the industry’s DNA, from the days when corner drugstores sold morphine, heroin, and cocaine, to the past two decades of dangerously overprescribed opioids. Pharma also uncovers the real story of the Sacklers, the family that became one of America’s wealthiest from the success of OxyContin, their blockbuster narcotic painkiller at the center of the opioid crisis.
I think one of the things that gets lost when we talk about Eroom's law is that the original data points were established before congress passed the Kefauver-Harris amendments in 1962 which set standards for clinical trials, iNDA process, and basically required that drugs show efficacy before they could be marketed.
An important part of those amendments is they made the drug companies go back and review the 4,000 drugs already on the market and provide evidence on their efficacy. It took FDA a long time to work through that backlog, but when they did:
"In January 1968, the Drug Efficacy Study panels finally reported their conclusions to the FDA. They had reviewed over 16,500 therapeutic claims for 4,000 pre-1962 drugs. Only 434, about 12 percent of those examined, delivered on all their promised claims. Seven hundred and sixty-nine were marked as 'ineffective'" [0].
I bring that up to say two things:
1) Our baseline in examining Eroom's law is a bit skewed because standards have been going up since the graph begins.
2) We should be careful in how we change those standards. Many of them were bought with patients lives.
I need to go now, but I do want to address your comment on pricing later.
Thank you again. Really great work.
[0] Pharma - Gerald Posner - Pg 224. https://www.amazon.com/Pharma-Greed-Lies-Poisoning-America-e...
